Forced degradation and impurity profiling: Recent trends in analytical perspectives

被引：126

作者：

Jain, Deepti ^{[1
]}

Basniwal, Pawan Kumar ^{[1
,2
]}

机构：

[1] Rajiv Gandhi Technol Univ, Sch Pharmaceut Sci, Bhopal 462033, Madhya Pradesh, India

[2] LBS Coll Pharm, Jaipur 302004, Rajasthan, India

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2013年 / 86卷

关键词：

Impurity; Forced degradation profiling; Analytical perspectives; active pharmaceutical ingredient; Drug products; PERFORMANCE LIQUID-CHROMATOGRAPHY; ACTIVE PHARMACEUTICAL INGREDIENT; INDICATING HPLC METHOD; RESPONSE FACTOR DETERMINATION; TANDEM MASS-SPECTROMETRY; STRUCTURAL ELUCIDATION; LC-MS; POTENTIAL IMPURITIES; STRESS DEGRADATION; DRUG SUBSTANCE;

D O I：

10.1016/j.jpba.2013.07.013

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

This review describes an epigrammatic impression of the recent trends in analytical perspectives of degradation and impurities profiling of pharmaceuticals including active pharmaceutical ingredient (API) as well as drug products during 2008-2012. These recent trends in forced degradation and impurity profiling were discussed on the head of year of publication; columns, matrix (API and dosage forms) and type of elution in chromatography (isocratic and gradient); therapeutic categories of the drug which were used for analysis. It focuses distinctly on comprehensive update of various analytical methods including hyphenated techniques for the identification and quantification of thresholds of impurities and degradants in different pharmaceutical matrices. (C) 2013 Elsevier B.V. All rights reserved.

引用

页码：11 / 35

页数：25

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